Shifting paradigms: Reframing coverage of antiobesity medications for plan sponsors

With the recent approvals of highly effective glucagon-like peptide-1 (GLP-1) receptor agonists for weight loss, there has been renewed interest in the debate over pharmacy coverage for antiobesity medications. All stakeholders, including plan sponsors, pharmacy benefit managers (PBMs), and drug manufacturers, have responsibility to ensure that people living with obesity have access to weight management medications. Managed care pharmacy has a role to play in the accessibility of antiobesity medications through benefit design. Typical PBM benefit elections exclude the category of weight loss medications and offer the plan sponsor to opt-in for coverage. Best practices for PBMs should be to include the category of weight loss medications as a core element of coverage. Switching to an opt-out election will encourage plan sponsors to include the coverage as a standard benefit offering. PBMs can also ensure the appropriate patient populations are receiving treatment by enforcing utilization management parameters or authorization criteria. Plan sponsors provide varying coverage of antiobesity medications, despite studies demonstrating that even a modest 5% reduction in weight from baseline translates to improved health outcomes and reduced medical costs. Employers have struggled in trying to promote healthy lifestyles and weight loss for employees by offering wellness programs and financial incentives, amounting to an estimated $8 billion industry. Historically, these programs have failed to demonstrate evidence of value and result in no significant changes in weight among their targeted employees. Employer’s wellness dollars would be better reallocated to providing coverage of antiobesity medications such as GLP-1 receptor agonists with demonstrated, sustained weight loss in clinical studies. Perhaps the largest concern facing plan sponsors is the estimated budgetary impact of providing coverage for these agents. Drug manufacturers can step in to encourage formulary uptake of high-cost antiobesity medications. Manufacturers could consider outcomes-based contracts to link coverage and reimbursement to real-world performance to temper plan sponsors’ apprehension. Plan sponsors are already shouldering the increased costs in medical expenditures associated with obesity. By partnering with drug manufacturers, plan sponsors would be able to reduce their financial risk and see improvements in their medical spend. As the prevalence of obesity continues to rise in the United States, these and other collaborative best practices are essential to ensure equitable treatment options and to protect the sustainability of the health care system. The increase in prevalence of obesity is a major focus of concern among national and global health organizations. Obesity is a common, chronic disease that affects adults and children and is a serious health-risk. The Centers for Disease Control and Prevention defines obesity as body mass index (BMI) (weight in kilograms divided by height in meters squared) greater than 30 for adults and BMI-forage in the 95th percentile or greater for children.1 In the past 2 decades, the prevalence of obesity in adults in the United States increased from 30.5% to 42.4%.2 During the same period, the prevalence of severe obesity in adults (defined as BMI >40) nearly doubled from 4.7% to 9.2%. All states and territories are affected by obesity, with the highest prevalence in the South and the Midwest, and disproportionately impact racial and minority groups.3 Obesity is associated with poorer health outcomes and increased medical expenditures. Cardiovascular disease, hypertension, type 2 diabetes mellitus, hyperlipidemia, stroke, certain cancers, sleep apnea, liver and gallbladder disease, osteoarthritis, and gynecological problems are associated with obesity.4 The Diabetes Author affiliations


Shifting paradigms: Reframing coverage of antiobesity medications for plan sponsors
Libbi Green, PharmD; Patty Taddei-Allen, PharmD, MBA, BCACP, BCGP With the recent approvals of highly effective glucagon-like peptide-1 (GLP-1) receptor agonists for weight loss, there has been renewed interest in the debate over pharmacy coverage for antiobesity medications. All stakeholders, including plan sponsors, pharmacy benefit managers (PBMs), and drug manufacturers, have responsibility to ensure that people living with obesity have access to weight management medications.
Managed care pharmacy has a role to play in the accessibility of antiobesity medications through benefit design. Typical PBM benefit elections exclude the category of weight loss medications and offer the plan sponsor to opt-in for coverage. Best practices for PBMs should be to include the category of weight loss medications as a core element of coverage. Switching to an opt-out election will encourage plan sponsors to include the coverage as a standard benefit offering. PBMs can also ensure the appropriate patient populations are receiving treatment by enforcing utilization management parameters or authorization criteria.
Plan sponsors provide varying coverage of antiobesity medications, despite studies demonstrating that even a modest 5% reduction in weight from baseline translates to improved health outcomes and reduced medical costs. Employers have struggled in trying to promote healthy lifestyles and weight loss for employees by offering wellness programs and financial incentives, amounting to an estimated $8 billion industry. Historically, these programs have failed to demonstrate evidence of value and result in no significant changes in weight among their targeted employees. Employer's wellness dollars would be better reallocated to providing coverage of antiobesity medications such as GLP-1 receptor agonists with demonstrated, sustained weight loss in clinical studies.
Perhaps the largest concern facing plan sponsors is the estimated budgetary impact of providing coverage for these agents. Drug manufacturers can step in to encourage formulary uptake of high-cost antiobesity medications. Manufacturers could consider outcomes-based contracts to link coverage and reimbursement to real-world performance to temper plan sponsors' apprehension. Plan sponsors are already shouldering the increased costs in medical expenditures associated with obesity. By partnering with drug manufacturers, plan sponsors would be able to reduce their financial risk and see improvements in their medical spend.
As the prevalence of obesity continues to rise in the United States, these and other collaborative best practices are essential to ensure equitable treatment options and to protect the sustainability of the health care system. The increase in prevalence of obesity is a major focus of concern among national and global health organizations. Obesity is a common, chronic disease that affects adults and children and is a serious health-risk. The Centers for Disease Control and Prevention defines obesity as body mass index (BMI) (weight in kilograms divided by height in meters squared) greater than 30 for adults and BMI-forage in the 95th percentile or greater for children.¹ In the past 2 decades, the prevalence of obesity in adults in the United States increased from 30.5% to 42.4%.² During the same period, the prevalence of severe obesity in adults (defined as BMI >40) nearly doubled from 4.7% to 9.2%. All states and territories are affected by obesity, with the highest prevalence in the South and the Midwest, and disproportionately impact racial and minority groups.³ Obesity is associated with poorer health outcomes and increased medical expenditures. Cardiovascular disease, hypertension, type 2 diabetes mellitus, hyperlipidemia, stroke, certain cancers, sleep apnea, liver and gallbladder disease, osteoarthritis, and gynecological problems are associated with obesity.⁴ The Diabetes Prevention Study demonstrated that a 5% reduction in weight from baseline translates to improvement in health outcomes. 5 Adults with obesity are estimated to double their medical expenditures compared with their reference-weight counterparts, on average incurring $2,505 higher annual medical costs with increasing costs associated with higher severity of obesity. 6 Third-party payers paid for 88.5% of the total cost increase, with the largest increases in inpatient services and prescription drug expenditures. 6 ( Figure 1) The direct medical costs of obesity among adults in the United States was estimated to be $260.6 billion in 2016.6 Indirect (nonmedical) costs of obesity have also been studied, with time away from work owing to obesity being the most commonly measured. Estimates in 2008 of the national costs of obesity-attributable absenteeism in the United States range from $3.38 billion to $6.68 billion ($4.5 billion to $8.9 billion in 2022 USD) annually. 7

Plan Sponsors Should Consider Coverage of Antiobesity Medications
Given the high-cost burden on third-party payers for obese patients relative to reference-weight patients, and the significant advances in obesity treatment with GLP-1-related agents, plan sponsors should cover antiobesity medications to reduce excess weight and improve health for their members.
For decades, physicians, plan sponsors, and the public debated whether obesity is a chronic illness, a risk factor for other disease states, or a poor lifestyle choice and lack of willpower in people. With advances in technology leading to discovery of hormonal regulators directly impacting obesity, multiple professional organizations have published position statements defining obesity as a chronic illness. 8 Since the approval of the first antiobesity medication in the 1930s, dozens more have entered the market but were subsequently withdrawn because of severe adverse side effects and safety issues, including death. 9 Further, patients on antiobesity medications struggled to sustain clinically significant weight loss at chronically administered, tolerable doses. 9 In 2007, the US Food and Drug Administration (FDA) provided guidance that a 5% or higher weight loss should be used to demonstrate efficacy, a target that most antiobesity medications, although able to achieve short-term, were not able to achieve long-term. 9,10 This likely relates to the pathophysiology differences between patients who are in active weight loss and those maintaining weight loss. Treating obesity as a disease state remains a challenge for many patients and providers, who are faced with few treatment options. Without safe and effective medications to target weight loss, patients contend with nonpharmacologic interventions such as diet and exercise, often with disappointing results. Bariatric surgery is still the most effective, albeit invasive, treatment option, with sustained weight loss approaching 30% from baseline. 9 In recent years, the discovery and approval of glucagonlike peptide-1 (GLP-1) receptor agonists changed the obesity treatment landscape. Semaglutide, the first weekly GLP-1 agonist approved for chronic weight management, demonstrated significant long-term weight loss. Not only did individuals in the treatment arm experience a decrease in body weight of 14.9% vs 2.4% in placebo, but the medication was generally well tolerated, a stark contrast from the previous decades of weight management pharmacotherapy. 11 Results from the phase 3 SURMOUNT-1 trial demonstrated that tirzepatide, a dual glucose-dependent insulinotropic polypeptide/GLP-1 agonist, achieved sustained weight loss after 68 weeks between 15% and 20.1% across 3 doses compared with a 3.1% decrease with placebo. 12 The sustained weight loss results patients experienced with recently approved GLP-1 agonist-based agents far exceeds what patients historically achieved by 2 to 4 times. 9 Social media visibility, combined with direct-to-consumer advertising, fueled demand for GLP-1 agonists across the United States, which, along with supply chain issues, resulted in limited availability of semaglutide for several months in 2022. The media's attention to drug shortages also highlighted the lack of plan-sponsored coverage of these agents for most people. And even when there is coverage, patients usually have higher out-of-pocket costs. This combination of scenarios is thought to worsen existent health disparities because obesity rates are higher in lowincome communities. 13,14 Coverage of antiobesity medications varies across plan sponsors. A 2018 study of individually purchased health plans found that covered agents were generally for older drugs, which have lower efficacy and more adverse effects, whereas newer therapies tended to be covered with higher cost shares. 15 The largest employer-sponsored health care program in the United States, the Federal Employee Health Benefit (FEHB) completed a survey of their plans that revealed limited or no coverage for antiobesity medications. The FEHB recently issued communication for its 2023 plans that FEHB carriers are not allowed to exclude antiobesity medications from coverage based on a benefit exclusion or a carve out. 16 Shifting paradigms: Reframing coverage of antiobesity medications for plan sponsors semaglutide 2.4 mg provides an incremental or better clinical rating when compared with lifestyle modification, the current cost far exceeds industry commonly used cost-effectiveness thresholds. ICER estimates that to be considered cost-effective, semaglutide 2.4 mg would need to be discounted between 44% and 57% from current prices. 17 Although plan sponsors may have varying coverage of antiobesity medications, they use a variety of wellness programs, which typically include a weight loss/weight management component. Studies demonstrate mixed reviews with the ability of wellness programs to significantly impact health and economic outcomes for both patients and employers. A 2013-2015 study of employer-based financial incentives for weight loss exposed the failures of such workplace programs, resulting in no significant changes in weight among the study groups. 18 Despite the paucity

Best Practices on Implementing Coverage of Antiobesity Medications
One of the largest concerns facing plan sponsors is the estimated budgetary impact of providing coverage for the GLP-1 agonist-based medications. Although some of the other commonly used agents, such as phentermine, have been around for decades and are relatively inexpensive, the newer GLP-1 agonist-based agents indicated for weight loss retail for approximately $1,500 monthly. At annual costs approaching $18,000 with potentially a large percentage of members meeting the FDA-labeled indication, plan sponsors are concerned that there may not be enough health care dollars. 17 The Institute for Clinical and Economic Review (ICER) report published in October 2022 concluded that although

FIGURE 1
Adults With Obesity BMI=body mass index; PBM=pharmacy benefit manager.

FIGURE 2
Recommended Best Practices  Drug manufacturers may want to consider outcomes-based contracts to encourage formulary uptake of high-cost antiobesity medications. Outcomes-based contracts, which drug manufacturers and plan sponsors link coverage and reimbursement to real-world performance, are an emerging trend in European and overseas single-payer markets. 21 To date, their use has been limited in the US private sector, despite opportunities in which using outcomes-based contracts can reduce a plan sponsor's risk. Drug manufacturers and plan sponsors should continue to explore these outcomes-based arrangements.
In January 2023, the drug manufacturer Eisai announced pricing based on societal value for its new Alzheimer disease treatment, lecanemab, to promote broader patient access and support health care system sustainability. 22 For promising antiobesity medications manufacturers should demonstrate the antiobesity medication's price to real-world outcomes. Payers would likely want to see real-world evidence demonstrating not only sustained weight loss but also impacts to lower health care resource utilization and improvements in biomarkers in obesity-related comorbidities.
In summary, all stakeholders, including plan sponsors, PBMs, and drug manufacturers, are tasked with the responsibility to ensure that people living with obesity have access to weight management medications. of evidence demonstrating value, the wellness program industry, estimated as an $8 billion industry, is used by approximately 82% of large firms and 53% of small employers in the United States. 19 Employers' wellness dollars would be better spent going toward evidence-based weight loss interventions, such as providing coverage of antiobesity medications through their employee prescription benefits. A percentage of wellness program dollars could be reallocated to help cover the increase in pharmacy spend on antiobesity medications, with regular reassessment intervals to track improvement in other chronic diseases over time. To avoid disparities because of high out-of-pocket costs for patients, employers could offer programs to reduce coinsurance or bypass deductibles based on weight management program engagement. This could be a program to promote accountability, such as patients tracking their weight loss journey or medication adherence.
Pharmacy benefit managers (PBMs) can play a role in the uptake of antiobesity medications ( Figure 2). Typical PBM benefit design excludes the category of antiobesity medications on a standard plan offering. The plan sponsor has to opt-in for coverage for its members, sending the message to plan sponsors that coverage of antiobesity medications is an unnecessary benefit. Instead of framing coverage as an add-on, PBMs should set the default benefit design to include antiobesity medications and allow the option for plan sponsors to opt-out. This will encourage plan sponsors to adopt antiobesity medications as a standard benefit election.
Plan sponsors considering the addition of antiobesity medications to their formulary coverage have several options to ensure the appropriate patient populations receive Although these best practices are great first steps, additional innovative solutions are necessary. Managed care professionals must consider the potential unintended consequences of widening disparities while attempting to close the affordability gap. Obesity affects the lives of almost half of the US population and accounts for diminished health outcomes and increased health expenditures, disproportionately affecting low-income communities. To ensure sustainability of the health care system and to reverse the rising prevalence of obesity and obesity-related comorbidities, stakeholders can take steps to encourage effective and equitable treatment options.
Shifting paradigms: Reframing coverage of antiobesity medications for plan sponsors